Documentation checklist for Product Handling

Sl No Product handling Ref Doc No – 040747, 040334, 122470, Report

1. Do you have contracts in place with distributors for distribution Yes

of products
2. Are the quality requirements mentioned in the contracts yes

3. Are the updated quality procedures sent to distributors? Do you yes

have documentation that the procedures have been sent. Or
acknowledgement from the distributor for the receipt of
applicable procedures

4. Do you sample NN products in your affiliate If yes. We will have some more questions
NO
5. Do you release products or the distributor, based on TT summary Distributor
reports in your affiliate
6. Do you have a copy of TT summary reports/ product release No, if there is a temp deviation the distributor
done by the distributor will send the summary report for analysis.
7. Do you have IQ/PQ documentation for the computer where TMD yes
is installed
8. Do you have complete documentation on temperature deviations Yes
in 2007, 2008 reported to HQ till the release of product.

If destruction is advised by HQ in any case, do you have a copy yes

of destruction certificate

Prepared by: ROFE BA, Edition-1.0 Page 1 of 1